Mega GLA With Sesame Lignans [Discontinued] by Life Extension

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Oral borage seed oil does not seem to improve symptoms of atopic dermatitis. Details: Taking borage seed oil orally 500-4000 mg daily for up to 24 weeks does not seem to improve symptoms of atopic dermatitis in adults or children (7632,7633,11341,36805,36824). Meta-analyses of clinical trials also indicate that borage oil and gamma-linolenic acid from borage and other sources do not significantly affect atopic dermatitis (13758,88185).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. It is unclear if oral borage seed oil is beneficial for acne. Details: In patients with mild to moderate acne, preliminary clinical research shows that taking borage oil 2 grams providing gamma-linolenic acid levels of 400 mg daily for 10 weeks improves inflammatory and non-inflammatory acne lesion counts by 33% and 16%, respectively, when compared with baseline. Acne severity was also improved. These changes were significant when compared with a group receiving no treatment and were equivalent to patients taking 1000 mg each of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (105842).
• Acute respiratory distress syndrome (ARDS). Enteral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Borage seed oil, providing gamma-linolenic acid (GLA), has been investigated in combination with fish oil and antioxidants for improving outcomes in patients with ARDS. A meta-analysis of randomized controlled trials evaluating these ingredients, provided as a specific enteral formula (Oxepa, Abbott Nutrition) or a combination supplement given as a bolus, shows that there is no effect on overall all-cause mortality or ventilator- or ICU-free days when compared with generally isonitrogenous and isocaloric control formulas. A sub-group analysis of lower quality research shows that there may be a modest benefit for patients with a higher risk of mortality (105250). Two more recent meta-analyses have yielded similar results (105248,105249). Most studies included in these analyses investigated the use of Oxepa and found there was no effect on mortality when compared with control enteral formulas. However, studies investigating other sources of enteral or intravenous fish oil were also included in these analyses (105248,105249). In one of these analyses, some low- to very low-quality evidence suggests that use of Oxepa modestly reduces mortality at 28 days, as well as ICU length of stay and duration of mechanical ventilation (105248). However, these benefits were not found in the second meta-analysis (105249). Although most studies investigated the use of an enteral formula containing borage seed oil, fish oil was used alone or in combination in all included studies. Any benefit of borage seed oil alone is unclear from these meta-analyses.
• Alcoholism. Although there is interest in using oral borage seed oil for alcoholism, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Asthma. It is unclear if oral borage seed oil is beneficial for asthma. Details: Preliminary clinical research shows that taking borage seed oil containing gamma-linolenic acid levels of approximately 2 grams daily for 12 months does not improve asthma symptoms in patients with mild to moderate asthma when compared with placebo (36812).
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral borage seed oil for ADHD, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Cardiovascular disease (CVD). Although there is interest in using oral borage seed oil for CVD prevention, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Coronavirus disease 2019 (COVID-19). Oral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small open label trial of patients in the intensive care unit (ICU) with severe COVID-19 infection shows that taking 5 mL of a syrup containing borage oil, providing gamma-linolenic acid 100 mg, plus extracts of lemongrass, yarrow, chamomile, and chicory daily for 5 days in combination with standard care reduces the length of ICU stay by around 1 day but does not improve mortality rates when compared with standard care alone (112147). The validity of these findings is limited by a lack of placebo control. Further, it is unclear if these findings are due to borage, other ingredients, or the combination.
• Diabetes. Although there is interest in using oral borage seed oil for diabetes, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Hangover. Although there is interest in using oral borage seed oil for symptoms of hangover, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Neurodermatitis. Although there is interest in using oral borage seed oil for neurodermatitis, there is insufficient reliable information about the clinical effects of borage seed oil for this condition.
• Obesity. It is unclear if oral borage seed oil is beneficial in patients with obesity. Details: A very small clinical trial in adults aged 30-46 years with obesity shows that taking 4 capsules of a specific borage seed oil (Barlean's Naturals), providing gamma-linolenic acid 880 mg total, daily for 6 weeks does not improve resting metabolic rate or body mass index when compared with placebo. Improvements in triglyceride and high-density lipoprotein cholesterol levels were observed when compared with baseline; however, patients had normal lipid profiles at baseline (108755). Due to its very small size, this study may have been inadequately powered to detect a difference between groups.
• Periodontitis. It is unclear if oral borage seed oil is beneficial for periodontitis. Details: Preliminary clinical research shows that taking borage seed oil 3 grams daily for 12 weeks improves gingival inflammation but does not reduce plaque in patients with periodontitis when compared with placebo (36804).
• Premenstrual syndrome (PMS). Although there is interest in using oral borage seed oil for PMS symptoms, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose.
• Prematurity. It is unclear if formula containing borage seed oil is beneficial for neurodevelopment in premature infants. Details: Clinical research shows that giving infant formula supplemented with long-chain polyunsaturated fatty acids from borage oil and fish oil does not improve overall neurodevelopment at 9 or 18 months after term when compared with a control infant formula. However, in males, some but not all measures of neurodevelopment were modestly improved at 18 months. Additionally, length, but not weight, was improved in males, with no growth improvements in females. The infant formula in this study was supplemented with borage oil and fish oils to provide gamma-linolenic acid (GLA) 0.9 grams per 100 grams fat, as well as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) 0.1 and 0.5 grams per 100 grams fat, respectively (13745).
• Pressure ulcers. Enteral borage seed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with acute lung injury, preliminary clinical research shows that giving a specific enteral emulsion (Oxepa, Ross Laboratories) providing borage oil, fish oil, and vitamins A, C and E for 7 days does not improve the healing of existing pressure ulcers when compared with a control enteral formula. Although the number of pressure ulcers in the group given the borage oil-containing formula was lower when compared with the control formula, these patients also seemed to have fewer pressure ulcers at baseline and no statistical comparison was conducted. The clinical significance of this finding is unclear (105252).
• Rheumatoid arthritis (RA). Small clinical studies suggest that borage seed oil may be beneficial for reducing symptoms of RA. Details: Some small clinical studies show that taking borage seed oil in combination with conventional analgesics or anti-inflammatory agents might help decrease symptoms of RA after 6 weeks of treatment, with improvements sustained for up to 24 weeks. In these studies, borage seed oil decreased the number of tender joints by 36%, the tender joint score by 45%, the number of swollen joints by 28%, and the swollen joint score by 41% when compared to baseline. Borage seed oil 4.5-7.2 grams daily for up to 24 weeks was used in these studies (1985,8458).
• Seborrheic dermatitis. Preliminary research suggests that topical borage seed oil is beneficial for infantile seborrheic dermatitis. Details: Small clinical studies suggest that topical application of borage seed oil 0.5 mL twice daily can lead to resolution of symptoms within 10-12 days. After discontinuation of topical borage seed oil application, symptoms recurred within 1 week (7630,13305). After lesion resolution, borage seed oil has been applied 2-3 times each week until 6-7 months of age without lesion recurrence (7630). The validity of these findings is limited by the small study sizes and lack of comparator groups.
• Stress. Although there is interest in using oral borage seed oil for stress, there is insufficient reliable information about the clinical effects of borage seed oil for this purpose. More evidence is needed to rate borage for these uses.

(Read more about BORAGE)

POSSIBLY EFFECTIVE

• Diabetic neuropathy. Clinical research suggests that oral GLA may improve nerve function and symptoms of diabetic neuropathy in patients with type 1 and type 2 diabetes. Details: Two clinical trials in patients with type 1 or type 2 diabetes and diabetic neuropathy show that taking GLA 360-480 mg daily for 6-12 months improves measures of nerve function and symptoms of neuropathy, including muscle weakness, impaired tendon reflexes, and impaired sensation, when compared with placebo (1984,8926). GLA seems to be more effective in patients with better glucose control when compared with patients with poor glucose control (8926).

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Most research suggests that oral GLA does not improve the symptoms or severity of atopic dermatitis in children and adults. Details: A meta-analysis of 11 small clinical studies in children and adults with atopic dermatitis shows that taking GLA from borage oil or evening primrose oil does not improve the severity of atopic dermatitis when compared with placebo oils. Adult doses in these studies ranged from 132-720 mg daily for 3-24 weeks. Child doses ranged from 90-480 mg daily for 3-16 weeks (13758). Also, a more recent clinical study in adults with mild-to-moderate atopic dermatitis shows that taking a food product containing GLA 200 mg daily for 12 weeks does not improve skin hydration, itching, or redness when compared with a control (92868). Conversely, one small open-label clinical trial in infants with atopic dermatitis shows that taking GLA 3 grams daily for 4 weeks might reduce redness, itching, and use of antihistamines when compared to baseline (51042). The validity of these findings is limited by a lack of placebo control.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute respiratory distress syndrome (ARDS). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of randomized controlled trials evaluating GLA, fish oil, and antioxidants, provided as a specific enteral formula (Oxepa, Abbott Nutrition) or a combination supplement given as a bolus, shows that there is no effect on overall all-cause mortality or ventilator- or ICU-free days when compared with generally isonitrogenous and isocaloric control formulas. A subgroup analysis of lower quality research shows that there may be a modest benefit for patients with a higher risk of mortality (105250). Two more recent meta-analyses have yielded similar results. Although most of the studies included in these meta-analyses investigated the use of Oxepa, some studies investigating other sources of enteral or intravenous fish oil were also included (105248,105249). In one of these analyses, some low- to very low-quality evidence suggests that use of Oxepa modestly reduces mortality at 28 days, as well as ICU length of stay and duration of mechanical ventilation (105248). However, these benefits were not found in the second meta-analysis (105249). It is unclear if GLA, when used alone, is beneficial in patients with ARDS.
• Asthma. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with asthma shows that taking 10 grams of a medical food emulsion providing GLA 0.75 grams with eicosapentaenoic acid (EPA) 0.5 grams, or 15 grams of a medical food emulsion providing GLA 1.13 grams with EPA 0.75 grams, daily for 4 weeks does not improve self-reported overall symptoms of asthma and bronchodilator use at 2 or 4 weeks when compared with placebo. Another small clinical study shows that taking medical food EFF1009, providing GLA 0.75 grams and EPA 0.5 grams, daily for 4 weeks modestly reduces bronchodilator use and improves quality of life and symptoms such as wheezing when compared to baseline (105251). The validity of this finding is limited by the lack of a comparator group and a high dropout rate.
• Attention deficit-hyperactivity disorder (ADHD). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in drug-naïve children ages 6 to 12 years with mild to moderate ADHD shows that taking GLA 60 mg in combination with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily for 12 months results in some small beneficial effects on inattentive symptoms when compared with placebo. However, these changes are unlikely to be clinically useful. Also, there was no change in blood levels of fatty acids (111058). The effect of GLA itself is unclear from this study.
• Autism spectrum disorder. Although there has been interest in using oral GLA for autism spectrum disorder, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Back pain. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical trial in patients with back pain due to compressive radiculopathy syndrome shows that taking GLA 360 mg and alpha-lipoic acid 600 mg daily for 6 weeks while undergoing rehabilitation therapy reduces pain intensity and improves disability status when compared with rehabilitation therapy alone (20489). It is unclear if these findings are due to GLA, alpha-lipoic acid, or the combination.
• Breast cancer. It is unclear if oral GLA is beneficial in patients with breast cancer. Details: A small clinical study in patients with various stages of endocrine-sensitive breast cancer shows that taking GLA 2.8 grams daily along with tamoxifen for 6 weeks seems to improve the response to tamoxifen when compared with tamoxifen alone (5902).
• Hyperlipidemia. Although there has been interest in using oral GLA for hyperlipidemia, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Hypertension. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients with modestly elevated diastolic blood pressure (DBP) shows that taking a combination of GLA 0.12 grams plus eicosapentaenoic acid (EPA) 0.48 grams does not reduce DBP when compared with olive oil (13771). However, another small clinical study in patients with hypertension shows that taking 4 grams of an oil preparation rich in GLA, EPA, and docosahexaenoic acid (DHA) daily for 6 weeks reduces DBP when compared with sunflower seed oil (51022). It is unclear if these findings are due to GLA, other ingredients, or the combination.
• Mastalgia. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial in patients with mastalgia shows that taking GLA 100 mg daily in combination with vitamin C and vitamin B12 as methylcobalamin for 12 weeks does not improve the proportion of patients with minimal or no pain when compared with taking placebo (111059).
• Menopausal symptoms. Although there has been interest in using oral GLA for menopausal symptoms, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Pressure ulcers. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with acute lung injury shows that taking a specific enteral emulsion (Oxepa, Ross Laboratories) providing GLA from borage oil along with fish oil and vitamins A, C and E for 7 days does not improve the healing of existing pressure ulcers when compared with a control enteral formula. Although the number of pressure ulcers in the group given the GLA-containing formula was lower when compared with the control formula, these patients also had fewer pressure ulcers at baseline and no statistical comparison was conducted. The clinical significance of this finding is unclear (105252).
• Psoriasis. Although there has been interest in using oral GLA for psoriasis, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral GLA for RA, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rosacea. It is unclear if oral GLA is beneficial in patients with rosacea. Details: A small clinical study in adults with rosacea shows that taking GLA (Evoprim) 320 mg daily along with minocycline 50 mg twice daily for 8 weeks improves patient satisfaction and measures of skin hydration and increases the rate of treatment success, defined as an investigator global assessment score of 1 or lower, indicating clear or minimal symptoms, by 2-fold when compared with placebo plus minocycline (107927).
• Scleroderma. It is unclear if oral GLA is beneficial in patients with scleroderma. Details: A small clinical study in patients with scleroderma shows that taking GLA (dose unknown) for 6 months does not reduce symptoms of scleroderma when compared with placebo (1977).
• Ulcerative colitis. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with ulcerative colitis shows that taking a combination of GLA 1.6 grams, eicosapentaenoic acid (EPA) 270 mg, and docosahexaenoic acid (DHA) 45 mg daily for 12 months does not reduce symptoms when compared with placebo (51013). More evidence is needed to rate GLA for these uses.

(Read more about GAMMA-LINOLENIC ACID (GLA))

POSSIBLY EFFECTIVE

• Hypertension. Oral sesame oil seems to reduce blood pressure by a small amount. Details: Meta-analyses of clinical research involving patients with or without hypertension show that taking sesame, or the sesame constituent sesamin, can reduce both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (96179,108355,108357). One meta-analysis of eight clinical studies shows that sesame or sesamin can reduce SBP by 8 mmHg and DBP by 6 mmHg when compared with control. In a subgroup analysis of patients with hypertension, reductions in SBP and DBP were 11 mmHg and 9 mmHg, respectively. In a subgroup analysis by formulation, sesame oil was shown to reduce SBP and DBP by 13 mmHg and 10 mmHg, respectively, while whole sesame seed, ground seed, or sesame supplement lowered SBP by only 3 mmHg and did not lower DBP (96179). Another meta-analysis of clinical studies involving patients with hypertension, metabolic syndrome, or kidney failure shows that taking sesame oil reduces SBP and DBP by 3 mmHg and 2 mmHg, respectively, although benefits were limited to studies of less than 8 weeks (108355). Some research on sesame oil involved replacing other cooking oils with a specific brand of sesame oil (Idhayam Gingelly oil, V.V.V. & Sons) 35 grams daily for about 6-9 weeks. Patients included in these studies were also using atenolol, nifedipine, and/or hydrochlorothiazide as antihypertensives (27652,27654,27655). Other preliminary clinical research shows that using a 20:80 blend of sesame oil and rice bran oil (Vivo, Adani Wilmar) as cooking oil for 8 weeks improves blood pressure and lipid profile in patients with hypertension. In patients using nifedipine, using the oil blend seems to reduce systolic and diastolic blood pressure by an additional 2 to 2.2-fold over nifedipine alone (96180).

POSSIBLY INEFFECTIVE

• Cough. Oral sesame oil does not seem to be beneficial for cough in children. Details: Clinical research in children with an acute cough due to common cold shows that taking sesame oil 5 mL by mouth at bedtime for 3 consecutive days does not reduce cough strength or cough frequency when compared with placebo (27647).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there is interest in using topical sesame oil for aging skin, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Alzheimer disease. Although there is interest in using oral sesame for Alzheimer disease, there is insufficient reliable information about the clinical effects of sesame for this condition.
• Anemia of chronic disease. Although there is interest in using oral sesame for anemia of chronic disease, there is insufficient reliable information about the clinical effects of sesame for this condition.
• Anxiety. Although there is interest in using topical sesame oil for anxiety, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Bowel obstruction. It is unclear if oral sesame oil is beneficial for bowel obstruction. Details: Preliminary clinical research in adults with adhesive small bowel obstruction shows that giving sesame oil 150 mL through a nasogastric tube along with standard treatment reduces the need for surgical intervention when compared with standard treatment alone. Also, the resolution time of the obstruction was 6 hours faster and the duration of hospitalization was 4 days shorter for patients treated with sesame oil plus standard treatment when compared with standard treatment alone (27645). Standard treatment consisted of stopping oral intake of food, performing nasogastric tube decompression, administering intravenous fluids with electrolytes, and providing parenteral antibiotics if leukocytosis was present.
• Burns. It is unclear if topical sesame oil is beneficial for burns. Details: Preliminary clinical research in adults and children with partial thickness thermal burns covering less than 40% of body surface area shows that topical application with a moist exposed burn ointment (MEBO) containing sesame oil, beta-sitosterol, berberine, and other unspecified plant ingredients every 4 hours reduces the median time to 75% healing by 3 days (17 days vs. 20 days) and improves analgesic effects during the first 5 days of treatment when compared with a control group receiving cleansing with chlorhexidine 0.05%. The MEBO was left on the burn for 5 days, followed by removal and reapplication at 4 hourly intervals on day 5, to be left on until day 14 (13526).
• Cardiovascular disease (CVD). Although there is interest in using oral sesame for CVD, there is insufficient reliable information about the clinical effects of sesame for this condition.
• Cataracts. Although there is interest in using oral sesame for cataracts, there is insufficient reliable information about the clinical effects of sesame for this condition.
• Chemotherapy-induced phlebitis. It is unclear if massage with topical sesame oil is beneficial for chemotherapy-induced phlebitis. Details: Preliminary clinical research in patients with colorectal cancer and chemotherapy-induced phlebitis shows that applying 10 drops of sesame oil within a 10 cm radius of the affected veins as part of a 5-minute, twice-daily massage reduces pain after 7 days when compared with massage alone (103227).
• Child growth. It is unclear if massage with topical sesame oil is beneficial for child growth. Details: Preliminary clinical research in full-term healthy infants shows that administering a daily massage with sesame oil 20 mL for 4 weeks improves infant length by 1 cm, midarm circumference by 0.9 cm, and midleg circumference by 0.7 cm when compared with a control group that did not receive a massage (29722). It is unclear if these effects are due to sesame oil, massage, or the combination.
• Cognitive impairment. It is unclear if oral sesame is beneficial for cognitive impairment. Details: Clinical research in older adults with memory impairment shows that taking sesame oil cake extract (Keukdong H-Pharm Co., Ltd.) 500 mg three times daily for 12 weeks modestly improves some, but not all, measures of cognitive function when compared with placebo (108351). In addition, preliminary clinical research in patients with mild cognitive impairment shows that taking two capsules of a combination product containing the sesame constituent sesamin 5 mg and astaxanthin 3 mg daily for 12 weeks increases psychomotor and processing speed when compared with placebo. However, there was no effect on memory, attention, or overall severity of cognitive symptoms (99863). It is not clear if these effects are due to sesamin, astaxanthin, or the combination.
• Dental plaque. It is unclear if rinsing the mouth with sesame oil or pulling the oil through the teeth is beneficial for dental plaque. Details: Preliminary clinical research in children 12-14 years of age shows that rinsing with 10 mL of ozonated or non-ozonated sesame oil for 10 minutes daily for 15 days reduces plaque when compared with baseline. The ozonated sesame oil was superior to non-ozonated sesame oil, showing a similar improvement in plaque when compared with chlorhexidine mouthwash (103226). A small clinical study in healthy adults shows that pulling sesame oil 10 mL through the teeth for 15-20 minutes twice daily for 4 days has similar effects on full-mouth prevention of plaque regrowth, tooth staining, gingival index, and bleeding when compared with pulling coconut oil through the teeth (106038).
• Diabetes. It is unclear if oral sesame oil is beneficial for diabetes. Details: Meta-analyses suggest that taking sesame for 6-12 weeks modestly reduces levels of fasting blood glucose and glycated hemoglobin (HbA1c), but not insulin levels or insulin resistance, when compared with placebo, baseline, or other control. Sesame oil and seed flour, tahini, and sesamin were used in the included research (108350,108352,108355). Although most studies included in these meta-analyses were conducted in patients with type 2 diabetes, one study (103231) was conducted in patients with metabolic syndrome. One small clinical trial included in these meta-analyses shows that replacing other cooking oils with a specific brand of sesame oil (Idhayam Gingelly oil, V.V.V. & Sons) 35 grams daily for 45 days reduces blood glucose levels and HbA1c when compared with baseline in patients with diabetes who are also using glibenclamide (27654). Sesame oil has also been investigated in combination with rice bran oil. One preliminary clinical trial in patients with type 2 diabetes not using antidiabetes medications shows that using a specific 20:80 blend of sesame oil and rice bran oil (Vivo, Adani Wilmar) as the only cooking oil for 8 weeks reduces levels of fasting blood glucose by 14% and reduces HbA1c when compared with baseline. In patients taking glibenclamide 5 mg daily, using this oil blend reduces fasting blood glucose and HbA1c when compared with glibenclamide alone (96177). The use of sesame oil has also been investigated for improving cardiometabolic markers in patients with type 2 diabetes. Clinical research in adults taking antidiabetes medications shows that replacing regular dietary oils with sesame oil or a blend of sesame and canola oils for 9 weeks does not improve most cardiometabolic markers when compared with canola oil or sunflower oil as a control (108353).
• Gastric cancer. Although there is interest in using oral sesame for gastric cancer prevention, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Gingivitis. It is unclear if pulling sesame oil through the teeth is beneficial for gingivitis. Details: Preliminary clinical research in adolescent males with plaque-induced gingivitis shows that oil pulling with sesame oil for one minute daily each morning prior to brushing for 10 days reduces dental plaque and gingivitis when compared with baseline (27648). The validity of this finding is limited by the lack of a comparator group.
• Hemorrhoids. Topical sesame oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in adults with symptomatic mild to moderate (first- and second-degree) internal hemorrhoids shows that application of a cream containing sesame oil and aqueous extracts of guggul and Allium ampeloprasum as a thin layer to the anus twice daily for 3 weeks improves anal irritation and itching, bleeding, pain, defecation discomfort, and swelling sense when compared with baseline. In contrast, patients using a placebo cream experienced an improvement only in anal itching (105751). The poor study methodology and lack of statistical comparison to the placebo group limit the validity of these findings.
• HIV/AIDS-related wasting. Oral sesame has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with HIV shows that consuming 300 grams of a chickpea and sesame-based food supplement daily for 3 months, along with routine sulfamethoxazole-trimethoprim, improves weight gain, body mass index, and mid-upper arm circumference in 73% of patients, and results in improved physical performance in 78% of patients, when compared to baseline (27657). The validity of these findings is limited by the lack of a comparator group.
• Hyperlipidemia. It is unclear if oral sesame is beneficial for hyperlipidemia. Details: A meta-analysis of a limited number of clinical studies that included mainly patients without hyperlipidemia shows that consuming sesame 25-50 grams daily or using sesame oil 3.5-35 grams daily for up to 10 weeks does not reduce levels of total or low-density lipoprotein (LDL) cholesterol when compared with baseline (96181). However, a more recent meta-analysis with similar studies shows that consuming sesame reduces levels of total cholesterol by 16 mg/dL, although there is no effect on levels of LDL cholesterol or high-density lipoprotein (HDL) cholesterol (108357). Both analyses show that taking sesame reduces triglyceride levels by about 21 mg/dL (96181,108357). Significant heterogeneity of the included studies and patient populations limits the validity of these results.
• Insect repellent. Although there is interest in using topical sesame oil as an insect repellent, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Male infertility. It is unclear if oral sesame is beneficial for male infertility. Details: Preliminary clinical research in males with infertility shows that taking sesame 0.5 mg/kg daily for 3 months modestly improves sperm count and motility, but not sperm morphology, when compared with baseline (108356). The validity of these findings is limited by the lack of a comparator group.
• Menopausal symptoms. Although there is interest in using oral sesame for menopausal symptoms, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Metabolic syndrome. It is unclear if oral sesame oil is beneficial for improving metabolic parameters in adults with metabolic syndrome. Details: Preliminary clinical research in patients with metabolic syndrome shows that taking sesame oil 30 mL with or without vitamin E 400 mg daily for 8 weeks improves levels of fasting blood glucose, lipids, and blood pressure when compared with sunflower oil. In those taking sesame oil alone, total cholesterol and triglycerides were reduced by about 13 mg/dL, while low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol were not affected. In those also taking sesame oil with vitamin E, total cholesterol and triglycerides were reduced by 17 mg/dL and 21 mg/dL, respectively, while HDL cholesterol was increased by 4 mg/dL. Additionally, systolic and diastolic blood pressure were reduced by 10 mmHg and 8 mmHg, respectively, in those taking sesame oil alone, versus 15 mmHg and 9 mmHg, respectively, in those taking sesame oil with vitamin E (103231).
• Miscarriage. It is unclear if oral sesame is beneficial for the management of an incomplete miscarriage. Details: Preliminary clinical research in patients with incomplete abortion related to miscarriage shows that taking sesame seed twice daily for 5 days results in complete resolution of retained products of conception in 84% of individuals, based on a sonographic assessment, compared with 26% of those receiving expectant management as control. There was also a 2-day reduction in the duration of vaginal bleeding when compared with control. Each dose of ground sesame seed powder 30 grams was boiled in 200 mL water for 4 minutes and then filtered before drinking (108346).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral sesame oil is beneficial for NAFLD. Details: Clinical research in females with NAFLD shows that taking sesame oil 30 grams daily for 12 weeks reduces the severity of fatty liver in 89% of patients taking sesame oil, compared with 58% of those taking sunflower oil. There were also modest reductions in levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), but not alkaline phosphatase (ALP), when compared with sunflower oil. All patients were also consuming a 500-kcal hypocaloric diet (108354).
• Obesity. It is unclear if oral sesame is beneficial for weight loss. Details: Meta-analyses of clinical research show that taking sesame or sesame oil in doses of at least 35 grams daily reduces body weight by up to 2 kg and body mass index by up to 1 kg/m² when compared with no oil or a control oil. Clinical studies included in these meta-analysis enrolled patients with type 2 diabetes, hypertension, hypercholesterolemia, and others, and were not limited to overweight or obese individuals (108355,108357). A small clinical study in overweight individuals shows that replacing regular dietary oil with sesame oil for 9 weeks does not improve levels of most cardiometabolic risk factors, although there were modest beneficial effects on insulin (108349).
• Osteoarthritis. It is unclear if topical sesame oil is beneficial for knee osteoarthritis. Details: Preliminary clinical research in patients with osteoarthritis of the knee shows that applying sesame oil 1.5 mL to the affected knee three times daily for 4 weeks reduces pain and improves physical function when compared to baseline. These improvements were similar to those seen in patients applying diclofenac topical gel (103228).
• Osteoporosis. Although there is interest in using oral sesame for osteoporosis, there is insufficient reliable information about the clinical effects of sesame for this condition.
• Pain (acute). It is unclear if massage with topical sesame oil is beneficial for acute pain caused by blunt trauma. Details: One small clinical study shows that using a specific sesame oil (Saman sesame oil, Saman sesame oil Co.) topically as part of a light massage for 5 minutes twice daily for 9 days moderately reduces acute pain caused by blunt trauma to an extremity by day 6 when compared with a light massage with placebo oil. However, the sesame oil massage does not reduce the use of nonsteroidal anti-inflammatory drugs when compared with placebo oil (96178). A similar clinical study in the same population shows that using sesame oil extracted from tahini topically as part of a light massage for 5 minutes 3 times a day for 2 days improves pain severity, pain sensitivity, and heaviness of the painful site by about 20% when compared with baseline (106034). The lack of statistical comparison to the placebo group limits the validity of these findings.
• Peptic ulcers. Although there is interest in using oral sesame for peptic ulcers, there is insufficient reliable information about the clinical effects of sesame for this purpose.
• Rheumatoid arthritis (RA). It is unclear if oral sesame is beneficial for RA. Details: Preliminary clinical research in females with RA shows that taking the sesame constituent sesamin (Sesamin, Scivation, Inc.) 200 mg daily for 6 weeks improves physical function and reduces pain, the number of tender and swollen joints, and markers of inflammation such as C-reactive protein when compared with placebo (103230).
• Stroke. Although there is interest in using oral sesame for stroke, there is insufficient reliable information about the clinical effects of sesame for this purpose. More evidence is needed to rate sesame for these uses.

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POSSIBLY SAFE ...when borage seed oil is used orally or topically and appropriately. Borage seed oil has been used with apparent safety in clinical trials at a dose of up to 4 grams daily for up to 12 weeks (7632,8458,11341,13305,36804,88185,5244).

LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Tell patients not to use borage preparations that are not certified and labeled as hepatotoxic PA-free.

CHILDREN: POSSIBLY SAFE
when borage seed oil is used orally and appropriately. Borage seed oil has been used with apparent safety at a dose of 2 grams daily for 12 weeks (11341).

CHILDREN: LIKELY UNSAFE
when products containing hepatotoxic PAs are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic, mutagenic, and teratogenic. These constituents are also excreted in breast milk (12841,12842). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free. There is insufficient reliable information available about the safety of borage seed oil when used orally or topically during pregnancy or lactation.

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POSSIBLY SAFE ...when used orally and appropriately. GLA appears to be safe when taken in oral doses of up to 2.8 grams daily for up to a year (1983,7701,7702,8926,107927).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally in amounts commonly found in food. Sesame has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when sesame oil is used orally and appropriately, short-term. Sesame oil has been used with apparent safety in doses up to 35 grams daily for up to 12 weeks (96179,96180,108354). The sesame constituent sesamin has been used with apparent safety at doses of 200 mg daily for 6 weeks (103230) and 10 mg daily for 12 weeks (99863). Sesame oil 150 mL has also been administered via nasogastric tube with apparent safety as a single dose (27645). ...when sesame oil is used in a nasal spray, short-term. A specific nasal spray (Nozoil) containing sesame oil has been used with apparent safety for up to 20 days (27658,27659,27660). ...when sesame oil is applied topically (96178,103227,103228). There is insufficient reliable information available about the safety of other forms of sesame when used in medicinal amounts.

CHILDREN: POSSIBLY SAFE
when sesame oil is used orally and appropriately in medicinal amounts, short-term. Sesame oil 5 mL has been used safely at bedtime for up to 3 days (27647).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of sesame when used in medicinal amounts during pregnancy and lactation.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, borage seed oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details In healthy individuals, borage seed oil supplementation does not seem to affect platelet aggregation (36823). However, gamma-linolenic acid, a constituent of borage seed oil, seems to decrease platelet aggregation by 45% and increase the risk of bleeding by 40% in animal and clinical research (1979).

CYTOCHROME P450 3A4 (CYP3A4) INDUCERS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking borage with drugs that induce CYP3A4 might increase levels of pyrrolizidine alkaloid (PA) toxic metabolites.  Details Although borage seed oil contains little to no PAs, some borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Hepatotoxic PAs are substrates of CYP3A4, which converts these chemicals into toxic metabolites (12841,12860). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.

PHENOTHIAZINES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking borage sed oil with phenothiazines might increase the risk of seizures.  Details Borage seed oil contains gamma-linolenic acid (GLA). There is concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines. This is based on limited data from two reports published in the 1980s. In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with evening primrose, another source of GLA. However, none experienced an actual seizure (21013). In the other report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose 4 grams daily was added. One of these patients had a prior history of seizures (21010). It is unclear whether evening primrose had any additive epileptogenic effects with the phenothiazines, but there is no evidence that taking GLA-containing supplements alone can cause seizures (88187).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, GLA might increase the risk of bleeding when taken with anticoagulant or antiplatelet rugs.  Details Animal and human research suggests that GLA reduces platelet aggregation (1979).

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Taking sesame oil with antidiabetes drugs might increase the risk of hypoglycemia.  Details Clinical studies show that sesame oil can decrease plasma glucose and glycated hemoglobin (HbA1c) levels. Some clinical research in patients taking glibenclamide shows that using sesame oil or a blend of sesame oil and rice bran oil in place of other oil for cooking reduces plasma glucose more than glibenclamide alone (27654,28139,96177,108350,108352,108355). Monitor blood glucose levels closely. Dose adjustments might be necessary.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Taking sesame oil with antihypertensive drugs might increase the risk of hypotension.  Details Clinical research shows that replacing other cooking oil with sesame oil can lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with or without hypertension. There is also some evidence that sesame oil has additive effects in patients also taking atenolol, nifedipine, and/or hydrochlorothiazide (27652,27654,27655,96179,108355,108357). In patients using nifedipine, using a blend of sesame oil and rice bran oil for cooking reduces both SBP and DBP more than nifedipine alone (96180).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, sesame might increase the levels and clinical effects of CYP2C9 substrates.  Details In vitro, sesame inhibits CYP2C9 (11028). However, this interaction has not been reported in humans.

P-GLYCOPROTEIN SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, sesame might alter the transport of P-glycoprotein substrates.  Details In vitro research suggests that sesamin, a constituent of sesame, can inhibit the multi-drug transporter protein, P-glycoprotein (28319,28320). However, this interaction has not been reported in humans.

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, sesame might interfere with tamoxifen.  Details In animal research, sesame seed reduces the tumor-inhibitory effect of tamoxifen by reducing apoptosis and increasing proliferation (28110,28111). This interaction has not been reported in humans.

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General ...Orally, borage seed oil seems to be well tolerated. However, borage plant parts, such as the leaf, flower, and seed, that contain hepatotoxic pyrrolizidine alkaloid (PA) constituents should be avoided.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, and soft stools.
Serious Adverse Effects (Rare):
Orally: Borage plant parts that contain PA constituents can be hepatotoxic.

Gastrointestinal ...Orally, borage seed oil can cause soft stools, diarrhea, belching, and bloating (8013,11341).

Hepatic ...The pyrrolizidine alkaloid (PA) constituents of borage can cause significant hepatotoxicity (12841,12842). PAs can occur in borage leaf, flower, and seed; borage seed oil contains little to no PAs. Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with veno-occlusive disease (VOD). Subacute VOD causes vague symptoms with persistent liver enlargement (4021). Symptoms of acute VOD include colicky pains in epigastrium, vomiting and diarrhea, and ascites within several days. Enlargement and induration of the liver occurs within a few weeks (12842).

Oncologic ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially carcinogenic and mutagenic (12841,12842).

Pulmonary/Respiratory ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially pneumotoxic (12841,12842).

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General ...Orally, GLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects, including belching, bloating, diarrhea, dyspepsia, flatulence, nausea, and vomiting.

Gastrointestinal ...Orally, GLA may cause mild gastrointestinal effects such as dyspepsia, nausea, bloating, vomiting, soft stools, diarrhea, flatulence, and belching (7701,7702,8926,107927).

Hematologic ...Orally, GLA might prolong bleeding time (1979).

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General ...Orally, topically, or intranasally, sesame seems to be well tolerated.
Most Common Adverse Effects:
All routes of administration: Allergic reactions.

Dermatologic ...In a small clinical study, one patient using a cream containing sesame oil as well as aqueous extracts of guggul and Allium ampeloprasum complained of rash at the application site (105751). It is unclear if this reaction was due to sesame, other ingredients, or other factors.

Gastrointestinal ...There was a single case of diarrhea associated with oral sesame in a clinical trial (108356).

Immunologic ...Multiple cases of allergic response to sesame seed occurring after occupational, topical, intramuscular, or oral exposure have been reported (28157,28158,28159,28160,28161,28162,28163,28166,28167,28183)(28184,28185,28186,28188,108348). One study found that up to 0.5% of the United States population reports having a sesame allergy, and 0.23% of the population meets criteria for an IgE-mediated allergic reaction to sesame (100501). Allergic symptoms may be dermatologic, such as angioedema (28160,28167,108348), cheilitis (28207), dermatitis (28157,28166,28182,28185,28186), edema (28159), erythema (28167), pruritis (28167,108348), purpura (28188), flushing (108348), and urticaria (28159,28160,28162,108348); musculoskeletal (28188); respiratory, such as asthma (28159,28162), rhinitis (28162), wheezing (28167), and general breathing difficulties (108348); gastrointestinal, such as vomiting (28159,108348); and others such as conjunctivitis (28159), anaphylactic shock (28157,28159,28160,28167,28177,28178,28179,28180,28204,108348), and hemodynamic modifications (28169). In Canada, sesame accounted for 4% of pediatric food-induced anaphylaxis reactions presenting to emergency departments over a 10-year period. The majority of cases were mild to moderate in severity and occurred within 2 hours of exposure; however, about 3% occurred 2-8 hours after exposure. Epinephrine was the most common treatment, followed by antihistamines, inhaled beta-agonists, and corticosteroids (108348).
Approximately one-third of patients with IgE-mediated sesame allergy have reported previous use of epinephrine due to this allergy (100501). There is evidence that IgE-mediated sesame allergy is influenced by both genetic and environmental factors; there was a high correlation of the allergy between family members, especially siblings (28175).
Allergens believed to be responsible for sesame seed hypersensitivity include beta-globulin (28213); sesamol, sesamolin, and sesamin (28182,28207); storage proteins including ses i 1 and ses i 2 (2S albumins) (28132,28187,28211,28212,28216,28217), ses i 3 (a 7S vicilin-type globulin) (28187,28214), ses i 4 (28158), ses i 5 (28158), ses i 6 (an 11S globulin) (28132,28215), and ses i 7 (28215). Typically allergens in sesame seeds that cause reactions after oral intake have molecular weights ranging from 8-62 kDa (28208,28210).

Pulmonary/Respiratory ...In clinical trials involving a sesame oil nasal spray, minor adverse effects included adverse smell, oil dripping from the nose, and nasal blockage (27659).

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